Evaluation of the effect of melatonin supplementation on Insulin metabolism markers, parameters of oxidative stress and gene expression of PPAR-γ & ox-LDL in patients with diabetic nephropathy
Evaluation of the effect of melatonin supplementation on Insulin metabolism markers, parameters of oxidative stress and gene expression of PPAR-γ & ox-LDL in patients with diabetic nephropathy
Design
In this research, 60 patients with diabetic nephropathy who are eligible will be selected. Participants are randomly divided into two groups of intervention and control by computer software. The design of the study is the parallel blind randomized clinical trial.
Settings and conduct
60 patients with diabetic nephropathy who are eligible and referred to kidney clinic of Beheshti hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected. Fasting blood samples will be taken at baseline and after 12 weeks of intervention.
Participants/Inclusion and exclusion criteria
Diabetic nephropathy patients with GFR between 15 and 89 ml / min, moderate blood pressure, lack of willingness to cooperate, non-use of fluvoxamine and any antioxidant supplement, non-cardiovascular disease, cancer, inflammatory diseases, autoimmune and hyper, or Hypothyroidism, Lack of lactation and pregnancy, lack of working in the night shift, the absence of a specific disease that leads to hospitalization, lack of smoking and alcohol consumption, absence of urinary tract infection and any other proteinuria causes.
Intervention groups
Patients will be assigned to receive either melatonin (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Insulin resistance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150606022562N5
Registration date:2018-12-08, 1397/09/17
Registration timing:registered_while_recruiting
Last update:2018-12-08, 1397/09/17
Update count:0
Registration date
2018-12-08, 1397/09/17
Registrant information
Name
Fereshteh Bahmani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
fbahmani@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of melatonin supplementation on Insulin metabolism markers, parameters of oxidative stress and gene expression of PPAR-γ & ox-LDL in patients with diabetic nephropathy
Public title
The effect of melatonin in patients with diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
GFR 15 to 89 ml per minute
Moderate blood pressure (systolic pressure 140-160 and diastolic pressure 80-100 mmHg)
No specific cardiovascular disease, cancer, inflammatory diseases, autoimmune and hyper or hypothyroidism
Non-presence of urinary tract infection and other factors of proteinuria
Exclusion criteria:
Special illness that leads to hospitalization.
High blood pressure (systolic pressure upper than 160 and diastolic pressure upper than 100 mmHg)
Unwillingness to cooperate
Taking fluvoxamine and any antioxidant supplement
Working at night shifts
Smoking and alcohol consumption
Breastfeeding and pregnancy
Age
From 40 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed with simple method and random numbers generated by computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, researchers, data collectors, evaluators and data analyzers are not aware of which group is placebo or supplemented melatonin groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan university of medical sciences and health services
Street address
Kashan University of Medical Sciences, Ravand road
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.64
Health conditions studied
1
Description of health condition studied
diabetic nephropathy
ICD-10 code
N08.3*
ICD-10 code description
Glomerular disorders in diabetes mellitus (E10-E14 with common fourth character .2†)
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and 12 weeks after intervention.
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and 12 weeks after intervention.
Method of measurement
HOMA formula
Secondary outcomes
1
Description
Triglyceride
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Enzymatic kit
2
Description
HDL cholesterol
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Enzymatic kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Enzymatic kit
4
Description
QUICKI
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Calculation using QUICKI formula
5
Description
plasma Malondialdehyde
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
by Spectrophotometry method
6
Description
plsma protein carbonyl
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
by Spectrophotometry method
7
Description
plasma total Gluthatione
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
by Spectrophotometry method
8
Description
plasma total antioxidant capacity
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
by Spectrophotometry method
9
Description
gene expression of PPAR-γ
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Real-Time PCR method
10
Description
gene expression of ox-LDL
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Real-Time PCR method
11
Description
C reactive protein
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
by turbidimetric method
12
Description
Nitric oxide
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
by Spectrophotometry method
Intervention groups
1
Description
Intervention group: Taking 10 mg melatonin at night for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Taking placebo for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Dr. Alireza Soleymani
Street address
Qotb –e Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Fax
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Banafshe
Street address
Qotb –e Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
banafsheh_h@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fereshte Bahmani
Position
Associate Professor/ Academic staff member of the Department of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Medical Faculty, Kashan University of Medical Sciences, Ravand road
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
bahmani@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fereshte Bahmani
Position
Associate Professor/ Academic staff member of the Department of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Medical Faculty, Kashan University of Medical Sciences, Ravand road
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
bahmani@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Bahmani
Position
Associate Professor/ Academic staff member of the Department of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Medical Faculty, Kashan University of Medical Sciences, Ravand road
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
bahmani@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available